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V5MS Transducer

by Siemens Medical Solutions USA, Inc.

510(k) K121807

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK121807 Date10 Jul 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2571-2014 FDA Class II initiated 13 Aug 2014

    Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ITX
Device class
Class II
Regulation
21 CFR Part 892.1570
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The V5MS Transducer is a Class II ultrasound system designed for use in radiology applications. It functions as a diagnostic imaging component to facilitate clinical examinations.

This device is manufactured by Siemens Medical Solutions USA, Inc. and has received FDA 510(k) clearance under K121807. It is identified by product code ITX and is categorized as a moderate risk medical device.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical application for the V5MS Transducer?

    The V5MS Transducer is designed specifically for use in radiology applications. It functions as a diagnostic imaging component to facilitate clinical examinations within this medical specialty.

  • What is the regulatory status of the V5MS Transducer?

    The V5MS Transducer has received FDA 510(k) clearance under K121807. It is classified as a Class II moderate risk medical device and is identified by product code ITX.

  • Who is the manufacturer of the V5MS Transducer?

    This device is manufactured by Siemens Medical Solutions USA, Inc., located at 685 E. Middlefield Rd., Mountain View, CA 94043, United States.